On May 23, 2017, the FDA approved pembrolizumab for adult and pediatric patients with unresectable/metastatic microsatellite instability-high or mismatch repair deficient tumors. This approval marked the first targeted therapy to receive a tumor-agnostic approval and paved the way for a new paradigm in clinical oncology.
To date, there are many biomarkers, preclinical drugs, and FDA-approved therapies that are of intense interest due to their potential applications in a tumor-agnostic setting. NTRK inhibitors larotrectinib and entrectinib received tumor-agnostic approval for solid tumors harboring NTRK fusions in November 2018. RET inhibitor selpercatinib received tumor-agnostic FDA approval in September 2022 for adult patients with locally advanced/metastatic solid tumors harboring RET rearrangements.
This white paper from NeoGenomics explores the novel tumor-agnostic approach of testing for RET-rearranged tumors, identifying both the challenges and prospects of a new pan-tumor indication.
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